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Brachial Plexus BlockadeNCT03163472

Effect of Local Anaesthetic Volume on Axillary Brachial Plexus Block Duration

A study testing Axillary brachial plexus block with 10 mL oof local anaesthetic and Axillary brachial plexus block with 30 ml of local anaesthetic in people with Brachial Plexus Blockade, run by Cork University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Axillary brachial plexus block is an safe, effective and widely used technique for providing surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular injections are the only significant risks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brachial Plexus Blockade
What is being tested?
Axillary brachial plexus block with 10 mL oof local anaesthetic and Axillary brachial plexus block with 30 ml of local anaesthetic
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
14 Nov 2012to 7 Aug 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA 1-3
  • Patients aged >18 years
  • undergoing elective upper limb (forearm, wrist or hand) surgical procedures.

Who cannot join

  • Contraindications to regional anaesthesia
  • Hypersensitivity to amide local anaesthetics.
  • Chronic pain
  • Language barrier
  • Neuromuscular disorders or peripheral neuropathy
  • Body mass index > 35
Show all 10Show fewer
  • History of hepatic and renal insufficiency
  • Pregnancy
  • Cognitive or psychiatric disorder
  • Cardiac conduction abnormality.

About this study

Official title: A Comparison of the Effects of Two Volumes (10 vs 30 mL) of Lidocaine 2% With Epinephrine 1:200 000 on the Duration of Ultrasound Guided Axillary Brachial Plexus Block.

Axillary brachial plexus block is an safe, effective and widely used technique for providing surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular injections are the only significant risks. Traditionally, greater volumes of local anaesthetic have been administered to achieve successful axillary brachial plexus block, but recent studies have demonstrated that this can be achieved with even very low volumes of 2-4 mL lidocaine 1.5% per nerve or ultra low volume of 1 mL lidocaine 2% per nerve.

Administration of 30mL (vs 10 mL) lidocaine 2% with epinephrine 1:200 000 prolongs the sensory and motor block duration of ultrasound guided axillary brachial plexus block for elective upper limb surgical procedures.

Read more

Primary Outcome:

The primary outcome will be the overall duration of sensory block.

Secondary Outcomes:

Duration of motor block Time to onset of the block. The quality of block intraoperatively Time to first request of postoperative opioid analgesia. Total opioid consumption at 24 hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.

Read the detailed description

Peripheral nerve blocks provide significant benefits to patients, including improved analgesia and decrease in general anaesthesia-related adverse effects. Ideally peripheral nerve block provides rapid onset and substantial perioperative analgesia. Use of ultrasound guidance in peripheral nerve blocks offers significant advantages compared to alternative techniques. It improves block success rate and shortens onset time.

To compare the effects of local anaesthetic volumes (10 vs 30 mL) of lidocaine 2% with epinephrine 1:200 000 on the duration of sensory and motor block following ultrasound guided axillary brachial plexus block.

Methods:

It is a prospective, randomized, observer blinded study. With institutional ethical approval and having obtained written informed consent from each, 30 patients will be studied.

Randomization and blinding:

Using a computer generated and sealed envelope technique, 30 patients will be randomly allocated in to one of two groups.

Group 1: patients will receive 10 ml of lidocaine 2% with epinephrine. Group 2: patients will receive 30 ml of lidocaine 2% with epinephrine.

Sample size and statistical analysis:

Sample size calculation will be based on duration of sensory block as the primary outcome parameter. Kaabachi et al found a sensory duration of axillary brachial plexus block (with 30 mL of lidocaine 1.5%) of 126 (SD=48) mins. The minimum sample size required to have a 90% probability of detecting a decrease in duration of 60 mins (level of significance 0.05) will be 13 patients per group using an unpaired student's t test. Total recruited 30.

Anaesthetic procedure:

Having established intravenous access, standard anaesthetic monitoring will be applied. Premedication with midazolam will be administered as clinically indicated (to a maximum of 3 mg). The operative arm will be abducted and externally rotated with elbow flexed at 90 degrees. Under strict aseptic condition, ultrasound guided axillary brachial plexus block will be performed. Having identified musculocutaneous, median, radial and ulnar nerves, a 50mm 22-gauge ultraplex short bevel insulated needle will be used with in-plane approach to block each nerve with either 2.5 ml (10 mL group) or 7.5 ml (30 mL group). All blocks will be performed by single operator experienced in the ultrasound peripheral nerve blocks.

Block assessment:

When the block procedure has been completed, a blinded observer will assess the onset of sensory and motor block15 in the innervation of each nerve every 5 mins, until surgical anesthesia is achieved or 30 mins have elapsed. Surgical anesthesia will be defined as a motor score ≤2, with absent sensation to cold and pinprick. Each nerve distribution will be individually assessed. Onset time will be measured from conclusion of the block (t=0) to attainment of surgical anesthesia. Block will be deemed failure if surgical anesthesia has not been achieved at 30 mins in one or more of the four nerve distribution. In case of failure, an additional rescue block or conversion to general anesthesia will be performed. Data from these patients will be analysed separately.

Intraoperative period:

All patients will receive 1 g of paracetamol and diclofenac 75 mg iv during surgery. In case of patients discomfort sedation and rescue analgesia in the form of fentanyl 25 micrograms aliquots IV will be administered to a maximum of 100 micrograms.

Postoperative period:

Upon arrival to recovery room, sensory and motor function will be assessed every 15 mins by a blinded observer.15 Assessment will be performed for each nerve separately. Block regression is defined as a return of sensation to cold and pinprick with motor power score ≥3 in any nerve region. Time to first request of postoperative analgesia and total opioid consumption for 24 hrs will be noted. Postoperative analgesia will be prescribed as paracetamol 1 g 6 hourly and diclofenac sodium 75 mg 12 hourly. Oxycodone 5-10 mg orally 4-6 hourly will be administered as rescue analgesia.

Primary Outcome:

The primary outcome will be the overall duration of sensory block.

Secondary Outcomes:

Duration of motor block Time to onset of the block. The quality of block intraoperatively Time to first request of postoperative opioid analgesia. Total opioid consumption at 24 hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.

Being tested
Axillary brachial plexus block with 10 mL oof local anaesthetic, Axillary brachial plexus block with 30 ml of local anaesthetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary brachial plexus block with 10 mL oof local anaestheticProcedure or surgery

    patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.

  • Axillary brachial plexus block with 30 ml of local anaestheticProcedure or surgery

    patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.

Study groups in NCT03163472
Study groupRoleWhat they receive
10 ml of lidocaine 2% with epinephrineActive comparatorpatients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Receives: Procedure: Axillary brachial plexus block with 10 mL oof local anaesthetic
30ml of lidocaine 2% with epinephrineExperimentalpatients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Receives: Procedure: Axillary brachial plexus block with 30 ml of local anaesthetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Duration of Sensory Block.

    Duration of sensory block of ultrasound guided brachial plexus block

    Measured: 24 hours

Secondary outcomes (5)
  1. Duration of Motor Block

    The total duration of motor block

    Measured: 24 hours

  2. Time to Onset of the Block

    Time to overall onset time for block

    Measured: 6 hours

  3. Time to First Request of Postoperative Opioid Analgesia

    Post-operative, Time to first request of opioid analgesia by the participants

    Measured: 24 hours

  4. Opioid Consumption

    overall cumulative opioid consumption dose of the participants

    Measured: 24 hours

  5. Number of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia"

    We recorded the the number of participants with adverse effects like nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia during the perioperative period.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study start14 Nov 2012
  3. Primary completion7 Aug 2013
  4. Study completion7 Aug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03163472
Sponsor's protocol ID
ECM 4 (J)
Status last verified
Sep 2021
First submitted
7 May 2017
Last updated
4 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Axillary brachial plexus block with 10 mL oof local anaesthetic and Axillary brachial plexus block with 30 ml of local anaesthetic in people with Brachial Plexus Blockade, run by Cork University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Duration of Sensory Block. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.

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